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PRO 2000 elicits a decline in genital tract immune mediators without compromising intrinsic antimicrobial activity

Marla J Keller1, Esmeralda Guzman, Ehsan Hazrati

  • 1Department of Medicine, Mount Sinai School of Medicine, New York, New York 10029, USA.

AIDS (London, England)
|February 16, 2007
PubMed
Abstract

Insights

PRO 2000 vaginal gel did not increase inflammation and maintained antimicrobial activity, despite a modest reduction in some immune factors. This suggests PRO 2000 is a safe microbicide option for women.

Area of Science:

  • Vaginal immunology
  • Microbicide research
  • Infectious disease prevention

Background:

  • Vaginal microbicides are crucial for preventing infections.
  • Effective microbicides must preserve mucosal immunity.
  • PRO 2000 is a potential microbicide under investigation.

Purpose of the Study:

  • To assess the impact of PRO 2000 gel on mucosal immunity mediators.
  • To evaluate the effect on intrinsic antimicrobial activity in the vagina.
  • To compare PRO 2000's effects against a placebo.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial.
  • 24 healthy, abstinent women received 14 daily applications of PRO 2000 or placebo.
  • Cervicovaginal lavage samples analyzed for cytokines, chemokines, defensins, and antimicrobial activity.

Main Results:

  • No pro-inflammatory cytokines were elevated; some protective factors (IL-1Ra, Ig, HBD-2) were lower with PRO 2000 but returned to baseline.
  • The reduction in immune mediators did not impair anti-HIV, anti-HSV, or anti-bacterial activity.
  • Menstrual cycle phase influenced protein levels, with a greater decline in PRO 2000 users.

Conclusions:

  • PRO 2000 did not induce inflammation, unlike nonoxynol-9.
  • A modest decrease in immune mediators was observed, but without compromising antimicrobial defense.
  • PRO 2000 appears safe for vaginal use, preserving essential host defense mechanisms.

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